Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the reference product sponsor. Still, the Court directed the Federal Circuit to revisit Amgen’s state law claims to determine whether such conduct is “unlawful” under California’s unfair competition laws and/or whether the Biologics Price Competition and Innovation Act (BPCIA) preempts any remedies available under state law. Here, we consider how the Federal Circuit may address these issues.

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Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic company True Health was not liable for contributory or induced infringement of claims directed to treating patients diagnosed by the blood test.  Continue reading this entry

Supreme Court Biosimilar Patent Dance Decision Largely Favors Biosimilars

On June 12, 2017, the Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc. (No. 15-1039), deciding that 42 U.S.C. § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application, and that 42 U.S.C. §262(l)(8)(A) permits a biosimilar applicant to provide 180-days premarketing notice “either before or after receiving FDA approval.”  Although the Court left open the possibility that California state law might provide another remedy for Sandoz’s decision not to share its biosimilar application with Amgen and engage in the biosimilar patent dance, it seems unlikely that the Federal Circuit will find both that Sandoz’s decision was “unlawful” and that any additional state law remedies are not preempted by the Biologics Price Competition and Innovation Act (BPCIA).

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Supreme Court Finds Patent Rights Exhausted Overseas

In Impression Products, Inc. v. Lexmark International, Inc., the Supreme Court reversed the en banc decision of the Federal Circuit, and held U.S. patents rights exhausted by the patent owner’s sale of a patented article anywhere in the world. The Court recognized a patent owner’s ability to impose restrictions through licensing arrangements, but emphasized that patent laws cannot be used against subsequent purchasers. This decision is important for pharmaceutical and biotechnology companies with global operations, especially those who may price their products differently in different countries.

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